Immediate Effects of Lucentis® in Conjunction With Photodynamic Therapy With Visudyne® in Exudative AMD(IECOMB) - Full Text View

Sponsors and Collaborators:	University Hospital Inselspital, Berne Novartis
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00413829

Purpose

This study is an evaluation of the short term effects on CNV perfusion of a same-day administration of photodynamic therapy (PDT) with Visudyne® and an intravitreal injection of Lucentis® (ranibizumab, 0.3 mg). An evaluation of the short term effects on CNV perfusion of this combined treatment is needed for better understanding of treatment effects.

Condition	Intervention	Phase
Age Related Macular Degeneration	Drug: Intravitreal ranibizumab with photodynamic therapy	Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Open-Label, Phase II Study Assessing Immediate Effects of Lucentis®(Ranibizumab) Administered in Conjunction With Photodynamic Therapy With Visudyne® in Patients With Choroidal Neovascularization Secondary to AMD

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

retinal thickness as measured by OCT over time [ Time Frame: 24 months ] [ Designated as safety issue: No ]
change of total lesion area, area of CNV and area of leakage over time as assessed by FA [ Time Frame: 24 months ] [ Designated as safety issue: No ]
mean change of VA from baseline over time [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2006
Estimated Study Completion Date:	March 2008
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Intravitreal injection, photodynamic therapy

Detailed Description:

The primary objective is to quantify the short term effects on CNV perfusion of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab. These short term effects will be assessed with visual acuity measurements and ophthalmic examinations including indocyanine green (ICG) and fluorescein angiography (FA) as well as Optical Coherence Tomography (OCT) measurements. The primary variable for this assessment is the incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography. Fluorescein and ICG angiography will be performed using a scanning laser ophthalmoscope (HRA). All angiographic studies and OCT examinations will be evaluated by the Bern Photographic Reading Center in a masked fashion. Visual acuity assessments will be performed with Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. A secondary objective is to explore the effect of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab:

on retinal thickness as measured by OCT over time
in change of total lesion area, area of CNV assessed by FA
in mean change of VA from baseline over time

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients 50 years of age or greater
Patients with subfoveal choroidal neovascularization lesions secondary to AMD, either predominantly classic, occult, or minimally classic.
CNV lesion in the study eye is ≤5400 microns in greatest linear dimension
Patients who have a best corrected visual acuity (BCVA) score between 73 and 24 letters, inclusively, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320) measured at 4 meters
Willing to return for follow up scheduled visits for a 6 months period
Only one eye will be assessed in the study. If both eyes are eligible, the one with the worse visual acuity will be selected for treatment and study unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment and study

Exclusion Criteria:

Patients who have a BCVA of < 33 letters (approximately 20/200) in both eyes
Prior treatment in the study eye with verteporfin, external-beam radiation therapy, vitrectomy, submacular surgery, other surgical intervention for AMD, or transpupillary thermotherapy
Previous or current intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
Focal laser photocoagulation (juxta-, extra- or subfoveal ) in the study eye
Concomitant use of chronic NSAIDs or steroids (by any route) for the duration of study participation (chronic use is defined as multiple doses taken daily for three or more consecutive days at any time during the study). Note that ASA (aspirin) taken as "low dose" up to 100 mg daily (qd) for prophylaxis of myocardial infarction (MI) and/or stroke is permitted during study
Current use or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol is excluded
History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Day One, or a history of post-operative complications within the last 12 months preceding Day One in the study eye (uveitis, cyclitis etc.)
History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with topical anti-glaucomatous medication).
Aphakia or absence of the posterior capsule in the study eye
Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia
Presence of a retinal pigment epithelial tear involving the macula in the study eye
Angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
Active intraocular inflammation (grade trace or above) in the study eye
Any active infection involving an eyeball adnexa
Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413829

Locations

Switzerland
Klinik und Poliklinik fuer Augenheilkunde, Inselspital
Bern, Switzerland

Sponsors and Collaborators

University Hospital Inselspital, Berne

Novartis

Investigators

Study Chair:	Sebastian Wolf, MD PhD	Klinik und Poliklinik fuer Augenheilkunde, Inselspital
Principal Investigator:	Ute Wolf-Schnurrbusch, MD	Klinik und Polklinik fuer Augenheilkunde, Inselspital

More Information

No publications provided

Responsible Party:	University Hospital Inselspital, Berne ( S. Wolf )
Study ID Numbers:	Aug1202
Study First Received:	December 19, 2006
Last Updated:	February 4, 2008
ClinicalTrials.gov Identifier:	NCT00413829 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:

age related macular degeneration
anti-VEGF therapy

Study placed in the following topic categories:

Metaplasia
Eye Diseases
Choroid Diseases
Verteporfin
Neoplasm Metastasis
Retinal Degeneration

Macular Degeneration
Bevacizumab
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes
Metaplasia
Eye Diseases
Choroid Diseases

Retinal Degeneration
Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

ClinicalTrials.gov processed this record on May 07, 2009